Malaria and Me: How Americans are Part of the World of Global Medicine Counterfeiting

In honor of World Malaria Day, we are reprinting this blog post by PSM Board member Tom Kubic, President and CEO of the Pharmaceutical Security Institute originally posted on the Sproxil blog April 3, 2012.

A key benefit of globalization is that lifesaving medications can be readily transferred from anywhere in the world to countries like Ghana, Kenya, and South Africa. Unfortunately, globalization has also brought criminal organizations that take advantage of the need for these medications. Criminals cheat patients out of lifesaving medications. They counterfeit everything from anti-fungals and antibiotics to chemotherapy and antivirals. A medication with no healing power is worthless. Whether the victim is a child with malaria in Lagos, or a child with cancer in Los Angeles, neither will be cured, and both may be killed by the counterfeiter’s malice.

In February, Americans were reminded of our interconnectivity to the global marketplace, when the FDA announced a counterfeit version of a cancer medication was found in the U.S. The authentic medication is made in California, and then distributed to U.S. hospitals and clinics by one of three authorized distributors. In the case of the counterfeit medication, it travelled around the world, crossing four continents, before arriving in the U.S. The manufacturer remains a mystery. What we do know is that the medication contained no active ingredient, and was a combination of starch, salt, paint thinner and other common chemicals.

Learn more about counterfeit medicine peddler Manuel Calvelo.

Will globalization so alter the American experience that patients here will face the counterfeit medicine challenge which now confronts many African nations?

African patients question whether or not their medications, some required to cure the most persistent diseases, will contain active pharmaceutical ingredients. Malaria Journal recently published a study that found fake artemisinin, the most effective antimalarial drug available, in eleven African countries. The fake antimalarial meds contained either the wrong mixture of active ingredients or insufficient medication to control the disease. While malaria is curable, the World Health Organization estimates that more than half a million people died of malaria in 2010, mostly African children. How many of these children died of a curable disease because they were unwittingly given counterfeit medication by loving parents? We don’t know. But we do know that the parasite that causes malaria is developing resistance due to its exposure to fake medications with less than correct dose to achieve a therapeutic result. Incurable malaria due to counterfeit medicines may kill even more children in the future.

FDA Special Agent Nancy Kennedy once said, “Make no mistake, it’s about the money,” when describing the people she’s investigated for counterfeit medications. These people are organized, and their concern is to make money irrespective of who dies. One such criminal, Manuel Calvelo, a Belgian, sold $1.4 million worth of misbranded and counterfeit drugs, as well as controlled substances to Americans. Pleading guilty to charges in January 2011, he admitted that for three years he operated websites pretending to be pharmacies and selling fake drugs. He’s just one drop in the bucket of global criminals that operate beyond U.S. borders to impact the lives of Americans. Future Manuel Calvelos should beware because in the coming weeks, the U.S. Congress is considering increasing the penalties for those convicted of trafficking in counterfeit medicines.

What can Americans do to prevent counterfeit medications from destroying the lives of so many? Firstly, we must recognize counterfeit drugs are in the market in many countries. In 2010, they were found in over 100 countries.

And secondly, avoid these counterfeits yourself by doing four things:

Avoid online drug sellers purporting to be pharmacies.

Only purchase medications from within the closed, secured drug supply chain.

Look for either the National Association of Boards of Pharmacy’s “VIPPS” approved online pharmacies or buy your medications from bricks and mortar pharmacies.

Track & Trace legislation
President Obama signed into law, on November 27, 2013, legislation to enhance the safety of the drug supply chain, which has seen a number of incidents in recent years threaten American patients. Learn more>>